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Childrens Pain and Fever

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This product has been discontinued

Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
July 21, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 160 mg/5 mL
Other brand names
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
July 21, 2023
Manufacturer
CalmCo LLC
Registration number
part343
NDC root
73282-2160
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This drug is designed to help you feel better by temporarily reducing fever and relieving minor aches and pains. It can be effective for discomfort caused by common conditions such as the cold, flu, headaches, sore throats, and toothaches. If you're experiencing any of these symptoms, this medication may provide you with some relief.

Uses

You can use this medication to temporarily reduce fever and relieve minor aches and pains. It is effective for discomfort caused by common conditions such as the cold and flu, as well as headaches, sore throats, and toothaches.

This medication is safe in terms of teratogenic effects, meaning it does not cause birth defects. You can feel confident using it for relief from these common ailments.

Dosage and Administration

When it comes to giving this medication to your child, the dosage depends on their weight and age. If your child weighs under 24 pounds and is under 2 years old, it's important to talk to a doctor before administering any medication. For children who weigh between 24 and 35 pounds and are aged 2 to 3 years, you should use one Single-Use Vial, which contains 5 mL of the medication.

If your child weighs between 36 and 47 pounds and is 4 to 5 years old, again, consult a doctor for guidance. For children aged 6 to 10 years who weigh between 48 and 71 pounds, you will need to use two Single-Use Vials, totaling 10 mL. Finally, for an 11-year-old who weighs between 72 and 95 pounds, the appropriate dose is three Single-Use Vials, which equals 15 mL. Remember, each dose should be given using the Single-Use Vials as specified in the dosage chart.

What to Avoid

It's important to be cautious when using this medication. You should not take it alongside any other drugs that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication includes acetaminophen, please consult your doctor or pharmacist for clarification.

Additionally, do not use this product if your child has a known allergy to acetaminophen or any of the inactive ingredients listed in the product. Always prioritize safety and seek professional advice if you have any questions or concerns.

Side Effects

Taking this medication can lead to some serious side effects, so it's important to be aware of them. If your child takes more than 5 doses in 24 hours, there is a risk of severe liver damage. Additionally, acetaminophen can cause severe skin reactions, which may include skin reddening, blisters, or a rash. If you notice any of these symptoms, stop using the medication and seek medical help immediately.

You should also consult a doctor if your child has a sore throat that is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. It's important to stop using the medication and contact a doctor if pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, new symptoms appear, or if there is redness or swelling, as these could indicate a serious condition.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if your child takes more than 5 doses in a 24-hour period. It's important to be aware of potential severe skin reactions, such as skin reddening, blisters, or rash. If you notice any of these symptoms, stop using the product and seek medical help immediately.

If your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor right away. Always ask a doctor before use if your child has liver disease or is taking the blood-thinning medication warfarin. You should also stop using the product and contact a doctor if pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, new symptoms appear, or if there is redness or swelling, as these could indicate a serious condition.

In case of an overdose, it is crucial to get medical help or contact a Poison Control Center immediately at 1-800-222-1222, even if there are no noticeable signs or symptoms.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Even if you don’t notice any signs or symptoms, getting prompt medical attention is crucial.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you experience any of these symptoms or are concerned about a possible overdose, don’t hesitate to reach out for help. Your safety is the top priority.

Pregnancy Use

When it comes to using acetaminophen during pregnancy, there is currently no specific information available about its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it's important to consult with your healthcare provider before taking acetaminophen or any medication. They can help you weigh the potential benefits and risks based on your individual health needs. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When giving medication to your child, it's important to follow the dosing guidelines carefully. For children under 2 years old who weigh less than 24 pounds, you should consult a doctor before administering any dose. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the recommended dose is one single-use vial (5 mL). If your child is 4 to 5 years old and weighs between 36 and 47 pounds, again, consult a doctor. For children aged 6 to 10 years who weigh between 48 and 71 pounds, the dose is two single-use vials (10 mL), and for those who are 11 years old and weigh between 72 and 95 pounds, the dose is three single-use vials (15 mL).

Be aware of some important warnings: Giving your child more than five doses in 24 hours can lead to severe liver damage. If your child experiences any severe skin reactions, such as redness, blisters, or rash, stop the medication and seek medical help immediately. If your child has a severe sore throat that lasts more than two days or is accompanied by other symptoms like fever or nausea, consult a doctor. Always check with a healthcare professional if your child has liver disease or is taking blood thinners like warfarin. Lastly, if your child's pain or fever worsens or lasts longer than the recommended time, or if new symptoms appear, seek medical advice.

Geriatric Use

When it comes to using CHILDREN'S PAIN AND FEVER - acetaminophen 160mg/5ml solution, there is no specific information available about its use in older adults. This means that if you are caring for an older adult, it’s important to consult with a healthcare professional before administering this medication. They can provide guidance tailored to individual health needs and any potential interactions with other medications.

Always ensure that any medication is appropriate for the person you are caring for, especially if they have existing health conditions or are taking other treatments. Your healthcare provider can help determine the safest and most effective options for managing pain and fever in older adults.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on renal impairment. However, it’s always best to discuss your individual situation with your healthcare provider, as they can offer personalized advice and monitor your health closely.

Make sure to keep your doctor informed about your kidney health, as they may need to consider this when prescribing medications or adjusting dosages in the future. Regular check-ups and open communication are key to managing your health effectively.

Hepatic Impairment

If your child has liver problems, it's important to be cautious with medications that contain acetaminophen. Taking more than 5 doses in a 24-hour period can lead to severe liver damage, which is the maximum daily amount for this product.

Before giving this medication to your child, please consult with a doctor if they have any liver disease. This ensures that you are making safe choices regarding their health and medication use.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if your child is taking warfarin, a blood-thinning drug. Combining these medications can increase the risk of bleeding, so ensuring that your healthcare provider is aware of all medications your child is taking is crucial for their safety. Always prioritize open communication about any treatments or tests to avoid potential interactions.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 68-77ºF (20-25ºC). This helps maintain its quality and performance.

When handling the product, be cautious: do not use it if the top flap of the carton is open, or if any vials are open or broken. These precautions are important to prevent contamination and ensure your safety.

Additional Information

No further information is available.

FAQ

What does this drug do?

This drug temporarily reduces fever and relieves minor aches and pains due to the common cold, flu, headache, sore throat, and toothache.

What should I do if my child is under 24 lbs?

If your child is under 24 lbs and under 2 years old, you should talk to a doctor for dosing advice.

How often can I give this medication?

You can repeat the dose every 4 hours while symptoms last, but do not give more than 5 doses in 24 hours.

Are there any warnings I should be aware of?

Yes, severe liver damage may occur if your child takes more than 5 doses in 24 hours. Additionally, watch for severe skin reactions and consult a doctor if symptoms persist.

Can I use this drug if my child is allergic to acetaminophen?

No, do not use this drug if your child is allergic to acetaminophen or any of the inactive ingredients.

What should I do if my child's sore throat is severe?

If your child's sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Is there any specific information regarding use during pregnancy?

The insert does not provide specific information regarding the use of acetaminophen during pregnancy.

How should I store this medication?

Store the medication at 68-77ºF (20-25ºC) and do not use if the carton is open or any vials are broken.

Packaging Info

Below are the non-prescription pack sizes of Childrens Pain and Fever (acetaminophen 160mg/5ml). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Pain and Fever.
Details

Drug Information (PDF)

This file contains official product information for Childrens Pain and Fever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The drug is supplied in a pouch containing 20 units. The packaging includes a Pouch Art File, which is referenced as part of the product's labeling.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the relief of minor aches and pains associated with conditions such as the common cold, influenza, headache, sore throat, and toothache.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For patients weighing under 24 lbs and under 2 years of age, it is recommended to consult a physician for appropriate dosing guidance. For children weighing between 24 to 35 lbs and aged 2 to 3 years, the prescribed dose is 1 Single-Use Vial (5 mL).

In the case of children weighing 36 to 47 lbs and aged 4 to 5 years, consultation with a physician is advised to determine the appropriate dosage. For those weighing between 48 to 71 lbs and aged 6 to 10 years, the recommended dose is 2 Single-Use Vials (10 mL). Finally, for patients weighing 72 to 95 lbs and aged 11 years, the dosage is 3 Single-Use Vials (15 mL).

The administration method involves the use of Single-Use Vials as specified in the dosage chart. It is essential to follow the recommended dosing guidelines and consult a healthcare professional when necessary.

Contraindications

Use of this product is contraindicated in the following situations:

  • Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

  • In patients with a known allergy to acetaminophen or any of the inactive ingredients in this product, as this may lead to severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of severe liver damage if more than 5 doses are administered within a 24-hour period. This dosage represents the maximum daily limit for this medication. Healthcare professionals should advise caregivers to strictly adhere to dosing guidelines to prevent potential hepatotoxicity.

Acetaminophen may also trigger severe skin reactions, characterized by symptoms such as skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance without delay.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended to rule out serious underlying conditions.

Before administering this product, healthcare professionals should inquire about the patient's medical history, particularly regarding liver disease. Additionally, it is crucial to consult a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin, as interactions may occur.

Patients should be advised to discontinue use and seek medical advice if any of the following occur: worsening pain that lasts longer than 5 days, fever that worsens or persists beyond 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious condition requiring further evaluation.

In the event of an overdose, immediate medical attention is essential. Caregivers should be instructed to contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent, as prompt intervention is critical.

Side Effects

Severe liver damage may occur in patients if more than 5 doses of the product are taken within a 24-hour period, which is the maximum daily amount recommended. Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional without delay.

Additionally, patients are advised to stop use and contact a doctor if pain worsens or lasts longer than 5 days, if fever intensifies or persists beyond 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious underlying condition.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Pain and Fever (acetaminophen 160mg/5ml). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Pain and Fever.
Details

Pediatric Use

Pediatric patients require careful consideration when administering this medication. Dosing is determined primarily by weight and age, as outlined in the following chart:

  • For patients under 24 lbs or under 2 years, consultation with a doctor is advised before use.

  • For those weighing 24 - 35 lbs (2 - 3 years), the recommended dose is 1 Single-Use Vial (5 mL).

  • For patients weighing 36 - 47 lbs (4 - 5 years), a doctor's consultation is necessary.

  • For children weighing 48 - 71 lbs (6 - 10 years), the dose is 2 Single-Use Vials (10 mL).

  • For those weighing 72 - 95 lbs (11 years), the recommended dose is 3 Single-Use Vials (15 mL).

Healthcare professionals should be aware of several important warnings. Severe liver damage may occur if a pediatric patient exceeds 5 doses in a 24-hour period, which is the maximum daily amount. Acetaminophen can also cause severe skin reactions, including skin reddening, blisters, and rash; if such reactions occur, use should be discontinued immediately, and medical assistance sought.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt medical consultation is recommended. Additionally, a doctor should be consulted prior to use if the child has liver disease or is taking the blood-thinning medication warfarin.

It is crucial to adhere to the dosing guidelines: confirm the dose using the weight chart, and if weight is unavailable, age may be used as a secondary measure. Doses may be repeated every 4 hours as needed, but should not exceed 5 doses in a 24-hour period or be administered for more than 5 days unless directed by a physician. If symptoms worsen or new symptoms arise, medical advice should be sought immediately.

Geriatric Use

There is no specific information regarding the use of CHILDREN'S PAIN AND FEVER - acetaminophen 160mg/5ml solution in geriatric patients. Therefore, healthcare providers should exercise caution when considering this medication for elderly patients.

Given the absence of data, it is advisable to monitor geriatric patients closely for any potential adverse effects or changes in efficacy. Additionally, healthcare providers may need to consider individual patient factors, such as renal and hepatic function, when determining the appropriateness of this medication in the elderly population.

Due to the lack of established guidelines for geriatric use, dose adjustments may be necessary based on the clinical judgment of the healthcare provider.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of acetaminophen in this population. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are adequately assessed.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if the maximum daily amount of more than 5 doses is exceeded within a 24-hour period. Therefore, dosage adjustments may be necessary for patients with compromised liver function.

Before administering this product, it is advised to consult a healthcare professional if the patient has a history of liver disease. This precaution is essential to ensure the safety and efficacy of the treatment in individuals with hepatic impairment. Regular assessment of liver function may be warranted to prevent potential adverse effects associated with acetaminophen use in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the management of an overdose may vary depending on the specific substance involved and the clinical presentation of the patient. Continuous monitoring and supportive care may be necessary to address any potential complications that arise from the overdose.

It is essential to gather as much information as possible regarding the substance taken, the amount, and the time of ingestion to facilitate appropriate treatment.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has revealed that acetaminophen may cause severe skin reactions. Reports indicate symptoms such as skin reddening, blisters, and rash associated with its use. In the event of a skin reaction, it is advised that the patient discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is essential to emphasize that prompt medical attention is critical, even if the patient does not exhibit any signs or symptoms of overdose.

Storage and Handling

The product is supplied in a tamper-evident carton. It is essential to inspect the packaging before use; do not utilize the product if the top flap of the carton is open or if any vials are found to be open or broken.

For optimal storage, the product should be maintained at a temperature range of 68-77ºF (20-25ºC). Proper handling and adherence to these storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Childrens Pain and Fever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Childrens Pain and Fever, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.